Management of Immune Checkpoint Inhibition-related Hepatitis Using Low-dose Corticosteroids

Exclusion Criteria12

• Previous Immune-related hepatitis that required systemic therapy
• Treatment for Immune-related hepatitis has already been initiated with high-dose corticosteroids (>0.5 mg/kg body weight)
• Immune-related hepatitis with bilirubin > 1.5 ULN or clinical suspicion of cholangitis or elevated INR (beyond baseline)
• Immune-related hepatitis with grade 4 at first presentation
• Prior irAE treated with systemic immunosuppression
• Simultaneous immune-related neurological toxicity or immune-related myocarditis (since these usually have to be treated with high doses of corticosteroids)
• a. Patients with other immune-related adverse events may be included according to the investigator's judgment
• Known liver disease (e.g., autoimmune hepatitis, active hepatitis B, C or E, hemochromatosis, liver cirrhosis Child-Pugh Score B or C, primary biliary cholangitis, primary biliary cirrhosis, Morbus Wilson)
• a. Patients with liver metastasis are eligible
• Patients receiving cancer treatment other than immune checkpoint inhibitors in parallel (e.g., tyrosine kinase inhibitors or chemotherapy).
• a. Patients who have received other cancer treatments in previous cycles are eligible, provided the treating physician does not assume any toxicity from the other medication.
• Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days prior to occurrence of IR hepatitis. Stable corticosteroid doses of < 10mg prednisone equivalent are allowed.